A Phase I/II Study of Neoadjuvant, Intra-arterial Administration of [177Lu]Lu-PSMA-617 in Subjects with High-risk, Localised or Locally Advanced Prostate Cancer who are Candidates for Radical Prostatectomy (LUPUS)

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-500838-28-00

Acronym

LUPUS

Enrollment

Registered

2023-11-27

Start date

2024-09-10

Completion date

Unknown

Last updated

2024-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

high-risk localized or locally advanced prostate cancer

Brief summary

Adverse Events related to intra-arterial [177Lu]Lu-PSMA-617 therapy, Days of delay of scheduled surgery due to AEs related to intra-arterial [177Lu]Lu-PSMA-617 therapy

Detailed description

PSA-response, Pathological response as measured by pathological complete response (pCR) and minimal residual disease (MRD), defined as a tumour burden of 5 mm or less in greatest dimensions.

Interventions

DRUGPluvicto 1 000 MBq/mL solution for injection/infusion

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Adverse Events related to intra-arterial [177Lu]Lu-PSMA-617 therapy, Days of delay of scheduled surgery due to AEs related to intra-arterial [177Lu]Lu-PSMA-617 therapy	—

Secondary

Measure	Time frame
PSA-response, Pathological response as measured by pathological complete response (pCR) and minimal residual disease (MRD), defined as a tumour burden of 5 mm or less in greatest dimensions.	—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026